FDA Device recall Z-0717-2023
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantita…
- FDA Device
- Class II
- ongoing
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class II recall of IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantita… by Siemens Healthcare Diagnostics, citing potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0717-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-04 |
| Published | 2022-12-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
Reason
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
Identifiers
| code_info | UDI:-DI: (01)00630414962269(10)826(17)20221130; (01)00630414962269(10)830(17)20221130; (01)00630414962269(10)831(17)202…UDI:-DI: (01)00630414962269(10)826(17)20221130; (01)00630414962269(10)830(17)20221130; (01)00630414962269(10)831(17)20221130; (01)00630414962269(10)832(17)20221130; (01)00630414962269(10)833(17)20221130. Kit Lots: 826, 830, 831,832, 833 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0717-2023%22
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